Tele: 561.316.3330
Breaking Medical Device News

Thursday, October 21, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeFDAAvicenna.AI Secures FDA Clearance for Its CINA Head Neurovascular Imaging Artificial Intelligence...

Avicenna.AI Secures FDA Clearance for Its CINA Head Neurovascular Imaging Artificial Intelligence Tool

July 14, 2020

Avicenna.AI today announced it has received 510(k) clearance from the US Food and Drug Administration for its CINA Head triage AI solution for neurovascular emergencies.

Avicenna.AI reports the FDA’s decision covers CINA’s automatic detection capabilities for both intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from CT-scan imaging.

Stroke is a leading cause of death in the US, with more than 795,000 strokes resulting in more than 100,000 deaths each year. It is estimated that up to a third of the most common type of stroke is caused by LVO, when a clot blocks the circulation of the blood in the brain. Around 1 in 10 strokes are thought to be caused by ICH, or bleeding that occurs inside the skull. Using a combination of deep learning and machine learning technologies, CINA Head automatically detects and prioritizes acute ICH and LVO cases within 20 seconds, seamlessly alerting the radiologist within their existing systems and workflow.

Dr. Peter Chang, radiologist, and co-founder of Avicenna.AI, said, “When dealing with a stroke, time is of the essence, and being able to prioritize effectively is critical to saving lives and improving outcomes. Not only does CINA Head help radiologists to identify pathologies quickly, but also to highlight those that require the most urgent care.”

CINA’s ICH detection capability was validated using data from 814 cases conducted at more than 250 imaging centers across the United States, with 96% accuracy, 91.4% sensitivity, and 97.5% specificity. The product’s LVO detection capability was validated based on 476 cases, with 97.7% accuracy 97.9% sensitivity and 97.6% specificity.

Cyril Di Grandi, co-founder, and CEO of Avicenna.AI said, “We’re excited to have received FDA clearance for CINA Head and are looking forward to working with emergency departments and stroke centers across the United States to help improve detection, decision-making, and patient outcomes. As a triage AI tool that identifies multiple pathologies, we believe that CINA Head delivers more value than AI tools or algorithms that only target a single condition.”

CINA Head is the first in a family of AI tools for emergency radiology being developed by Avicenna.AI. Subsequent products spanning the trauma and vascular fields are expected to be unveiled in the next 12 months.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Luciana Borio MD is a respected physician with vast experience in advancing major regulatory and policy agendas for the United States.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy